US7470254B2 - Needle with sealing valve - Google Patents

Abstract

A needle assembly (100) having a hollow needle (110) with a pointed distal end (112) and a proximal end (114). The assembly also includes a needle hub (120) having a distal hub end (122) fixedly connected to the needle (110), a proximal hub end (124) having an opening, and a passageway (126) extending therethrough between the distal end and the proximal end. A valve (140) is disposed within the passageway (126), wherein the valve comprises a sealing member (142) having at least one through-opening (150) disposed therein and a plunger (146) disposed proximate the sealing member (142) and slidable between a first position wherein the at least one through-opening (150) is closed such that the hollow needle (110) and the proximal hub end (124) are not in fluid communication with each other and a second position wherein the plunger (146) biases the at least one through-opening (150) to an open position, such that the hollow needle and the proximal hub end are in fluid communication with each other. A method of using the needle assembly (100) is also disclosed.

Description

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims priority from U.S. Provisional Patent Application Ser. No. 60/495,988, filed on 18 Aug. 2003.

FIELD OF THE INVENTION

The present invention relates to a catheter insertion needle having a valve incorporated into the needle hub.

BACKGROUND OF THE INVENTION

Catheters for the introduction or removal of fluids may be located in various venous locations and cavities throughout the body for introducing or removing fluids. Such catheterization may be performed by using a single catheter having multiple lumens. A typical example of a multiple lumen catheter is a dual lumen catheter in which one lumen introduces fluids and one lumen removes fluids. Catheterization may also be performed by using separate, single lumen catheters inserted through two different incisions into an area to be catheterized. Such multiple catheter assemblies are known as TESIO® catheters sold by Medical Components, Inc. of Harleysville, Pa.

Generally, to insert any catheter in a blood vessel, the vessel is identified by aspiration using an introducer device, such as a syringe having a long hollow needle in accordance with the Seldinger technique. Typically, a needle is attached to a syringe and inserted under the patient's skin, with the plunger being withdrawn as the needle is inserted. When blood enters the syringe attached to the needle, indicating that the vessel has been found, the syringe body is removed and a thin guide wire is introduced through the needle lumen and into the interior of the vessel. The needle is then removed, leaving a portion of the guide wire within the vessel and the remainder projecting outwardly to a point beyond the surface of the patient's skin. Other guide wire introducing devices and syringes are also available. At this point, the catheter is inserted by the physician over the guide wire using one of several known techniques.

In the case of single-lumen catheters typically used in multiple catheter assemblies (e.g., a Tesio® catheter), a physician may use an introducer sheath. If a Tesio® catheter is used for hemodialysis, for example, each catheter may be inserted in two separate veins. Alternatively, each catheter may be inserted in two different locations of the same vein, such as the internal jugular vein or in a single insertion site as described in U.S. Pat. No. 5,624,413. The introducer sheath is simply a large, stiff, thin-walled tube which serves as a temporary conduit for the permanent catheter which is being placed. The introducer sheath is positioned by placing a dilator device inside of the introducer and passing both the dilator and the introducer together into the vessel over the guide wire. The guide wire, which is partially within the vessel after insertion as described above, and the dilator are then removed, leaving the thin-walled introducer sheath in place. The catheter is then placed through the introducer sheath.

In each case, the first step is aspirating the vessel or area to be catheterized prior to introducing the guide wire. This is often troublesome, especially when aspirating blood vessels, due to the flashback of blood. Arterial blood may spurt from the needle insertion point with considerable force and may contact a physician or other attendant assisting the physician, causing the risk of contamination with blood borne pathogens, such as HIV virus or hepatitis. A second problem, which is of greater concern to the patient, is exposing certain venous blood vessels or other body cavities to atmospheric pressure. Veins are often under negative pressure as blood is being drawn back to the thoracic cavity due to the process of inspiration during the breathing cycle, and a hole in a venous blood vessel could lead to air being drawn into the blood vessel, creating an air embolism.

In other types of catheterization procedures, such as a pleural effusion where fluid which collects around the lungs is drained, it is important to have a closed system guide wire introduction device which prevents atmospheric air from entering the thoracic cavity. Breathing movement creates negative pressure in the thoracic cavity, which, in combination with the air in the lungs, keeps the lungs expanded. The introduction of air into the thoracic cavity could cause the lungs to partially collapse. It is therefore important during the insertion of a guide wire for catheterization that the risk of introducing air into the thoracic cavity or a vessel be minimized.

One attempt to solve these problems is disclosed in U.S. Pat. No. 5,613,663, which discloses a valve device within a two-piece housing that requires the valve to be assembled within the device prior to assembly of the two pieces that comprise the housing. However, the valve disclosed in this patent requires arterial blood pressure to close the valve. It would be beneficial to provide a valve that is housed in a one-piece housing to facilitate manufacturing of the device, and that includes a valve closure mechanism that does not require arterial blood pressure to close the valve.

BRIEF SUMMARY OF THE INVENTION

Briefly, the present invention provides a needle assembly comprising a hollow needle having a pointed distal end and a proximal end. The assembly also includes a needle hub having a distal hub end fixedly connected to the needle, a proximal hub end having an opening, and a passageway extending therethrough between the distal end and the proximal end. A valve is disposed within the passageway, wherein the valve comprises a sealing member having at least one through-opening disposed therein and a plunger disposed proximate the sealing member and slidable between a first position wherein the at least one through-opening is closed such that the hollow needle and the proximal hub end are not in fluid communication with each other and a second position wherein the plunger biases the at least one through-opening to an open position, such that the hollow needle and the proximal hub end are in fluid communication with each other.

The present invention also provides a method of inserting a guide wire into a blood vessel. The method comprises: providing the needle assembly comprising a hollow needle having a pointed distal end and a proximal end. The assembly also includes a needle hub having a distal hub end fixedly connected to the needle, a proximal hub end having an opening a passageway extending therethrough between the distal end and the proximal end; a valve disposed within the passageway, wherein the valve comprises a sealing member having at least one through-opening disposed therein; and a plunger disposed proximate the sealing member and slidable between a first position wherein the at least one through-opening is closed such that the hollow needle and the proximal hub end are not in fluid communication with each other and a second position wherein the plunger biases the at least one through-opening to an open position, such that the hollow needle and the proximal hub end are in fluid communication with each other. The method further includes the steps of: providing a body having a luer connector extending therefrom; providing a guide wire having a distal end; releasably connecting the body to the proximal end of the hub, wherein the luer connector disposes the plunger in a distal direction, wherein the plunger biases the at least one through-opening from a closed position to an open position; inserting the pointed distal end of the needle into the blood vessel; confirming proper placement of the needle in the blood vessel by drawing blood into the body; removing the body from the needle assembly, wherein the luer connector is disposed away from the plunger, wherein the sealing member biases the plunger in a proximal direction, and wherein the at least one through-opening returns to the closed position; inserting the distal end of the guide wire into the passageway, through the at least one through-opening, through the hollow needle and into the blood vessel; and removing the needle assembly from the blood vessel by sliding the needle assembly proximally along the guide wire.

The present invention also provides a needle assembly comprising a hollow needle having a pointed distal end, a proximal end, and a longitudinal axis extending between the distal end and the proximal end. A needle hub having a distal hub end is fixedly connected to the needle. The needle hub includes a proximal hub end having an opening and a passageway extending therethrough along the longitudinal axis between the distal hub end and the proximal hub end. A valve is disposed within the passageway. The valve comprises a sealing member having at least one through-opening disposed along the longitudinal axis and a plunger disposed proximate the sealing member and slidable between a first position wherein the at least one through-opening is closed such that the hollow needle and the proximal hub end are not in fluid communication with each other and a second position wherein the plunger biases the at least one through-opening to an open position, such that the hollow needle and the proximal hub end are in fluid communication with each other.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features of the invention. In the drawings:

FIG. 1 is a side profile view of a needle assembly according to the present invention.

FIG. 2 is an enlarged perspective view, in section, of the needle hub shown inFIG. 1, with a hub valve in a closed position.

FIG. 2A is a greatly enlarged partial side profile view ofFIG. 2, in section, showing retaining portions of the valve.

FIG. 3 is a perspective view, in section, of the needle hub ofFIG. 2, with a syringe opening the hub valve.

FIG. 4 is a perspective view, in section, of the needle hub ofFIG. 2, with a guide wire inserted through the hub valve.

FIG. 5 is a perspective view, in section, of the needle hub ofFIG. 2, with a bulb opening the hub valve.

FIG. 6 is a perspective view, in section, of an alternate embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

In the drawings, like numerals indicate like elements throughout. The terms “distal” and “proximal” refer to the insertion end and the connecting end, respectively, of the needle assembly according to the present invention. The terminology includes the words above specifically mentioned, derivatives thereof and words of similar import. The embodiments illustrated below are not intended to be exhaustive or to limit the invention to the precise form disclosed. These embodiments are chosen and described to best explain the principle of the invention and its application and practical use and to enable others skilled in the art to best utilize the invention.

Referring now toFIG. 1, a catheterinsertion needle assembly100 according to the present invention is shown. Theneedle assembly100 includes aneedle110 having a beveleddistal tip112 and aproximal end114. Theneedle110 includes ahollow cannulating portion116 that extends between thedistal tip112 and theproximal end114. Preferably, theneedle110 is constructed from stainless steel or some other suitable material.

A generallyhollow needle hub120 is fixedly connected to theproximal end114 of theneedle110. Preferably, thehub120 is of one-piece construction for ease of manufacture and cost issues. Thehub120 includes adistal end122 that is fixedly connected to and encompasses theproximal end114 of theneedle110. Thehub120 also includes an openproximal end124 and apassageway126 extending between theproximal end124 and thedistal end122, and in fluid communication with the cannulatingportion116 of theneedle110. A longitudinal axis127 (FIG. 2) extends between thedistal end122 and theproximal end124 along thepassageway126 and through theneedle110 between thedistal tip112 and theproximal end114.

Adistal end128 of thepassageway126 is conically tapered from a larger first diameter Dl to a smaller second diameter D2 that is generally the same size as the diameter of the cannulatingportion116 of theneedle110. Aproximal end130 of thepassageway126 has a large third diameter D3 that is sized and tapered to accept a standard luer lock fitting, as is well known by those skilled in the art. Theproximal end124 also includesmale threads132 to facilitate connection of theneedle assembly100 to an external device, such as a syringe. The step between first diameter Dl and third diameter D3 defines a forward stop for the valve and the support member and can be said to comprise a first inwardly directed protrusion of third diameter D3, that portion of the passageway containing thevalve140, which includes aseal142, asupport member144 and aplunger146.

Referring to the enlarged sectional view of thehub120 shown inFIG. 2, a second inwardly directed protrusion or retainingring133 is disposed within thepassageway126 between thedistal end128 and theproximal end130. Referring toFIG. 2A, the retainingring133 includes a taperedproximal face133aand a straightdistal face133bthat extends generally perpendicular to the length of thepassageway126, and is stoppingly engaged by the proximal end surface of the support member to retain the support member and perforce the valve within the passageway distally of the retaining ring, with the forward stop comprised by the first diameter Dl. Preferably, thehub120 is constructed from CYROLITE® Med 2Acrylic-Based Multipolymer Compound, produced by Cyro Industries, Orange, CT, although those skilled in the art will recognize that other suitable materials may be used.

Referring back toFIG. 2, avalve140 is disposed within thepassageway126. Thevalve140 includes aseal142, asupport member144, and aplunger146. Theseal142 is disposed proximate to thedistal end128 of thepassageway126 and is generally annularly shaped, with a generallytubular side wall147 and a closeabledistal portion148 that seals thepassageway126 to prevent fluid flow therethrough. Thedistal portion148 includes a plurality of slots or through-openings150 that extend generally radially from the center of thedistal portion148, preferably generally evenly angularly spaced, toward thesidewall147. Theseal142 is generally disposed about thelongitudinal axis127, with thelongitudinal axis127 extending through the intersection of the through-openings150 in thedistal portion148 of theseal142. Preferably, three slots or through-openings150 are present (only one through-opening150 is shown inFIG. 2), although those skilled in the art will recognize that more or less than three through-openings150 may be used. Preferably, theseal142 is constructed from silicone elastomer or some other suitable material so that, when thevalve140 is opened, as will be described in more detail later herein, the through-openings150 allow fluid flow through theseal142.

Thesupport member144 is disposed within thepassageway126 just proximal of theseal142. Thesupport member144 has a generally annularly shaped cross section and includes a recesseddistal portion154 sized to allow thesidewall147 of theseal142 to snugly surround the recesseddistal portion154 and to bias theseal142 to a most distal position within thepassageway126. The retainingring133 is so shaped and positioned to allow thesupport member144 to be inserted distally into thepassageway126, but restrains thesupport member144 from being removed proximally from thepassageway126. Referring now toFIG. 2A, thesupport member144 further includes an inwardly protruding retainingring156 disposed at aproximal end158 of thesupport member144. The retainingring156 includes a taperedproximal face156aand a straightdistal face156bthat extends generally perpendicular to the length of thepassageway126. Preferably, thesupport member144 is constructed from PELLETHANE® polyurethane, CYROLITE® acrylic-based compound, or some other suitable material.

Theplunger146 includes adistal portion160 that is disposed within thesupport member144 and aproximal portion162 that is disposed within thepassageway126 proximal of thesupport member144. Theplunger146 has a generally annularly shaped cross section. A mostdistal end164 of theplunger146 is generally conically tapered, preferably at an angle approximately equal to the conical taper of thedistal end128 of thepassageway126. A mostproximal end166 of theplunger146 includes aflange168 that extends approximately to the sidewall of thepassageway126. Aplunger passageway169 extends between the mostdistal end164 and the mostproximal end166 of theplunger146.

Theproximal portion162 of theplunger146 has a smaller outer diameter than thedistal portion160 of theplunger146, with a step163 (FIG. 2A) along its outer surface defining the interface between theproximal portion162 and thedistal portion160. When thedistal portion160 ofplunger146 is fully inserted into thesupport member144, the retainingring156 stoppingly engages thestep163 and retains theplunger146 within thesupport member144 so that thedistal portion160 of theplunger146 may not move proximally beyond the retainingring156. Thus,distal portion160 of theplunger146 is slidable distally between the retainingring156 and thedistal end128 of thepassageway126. Preferably, theplunger146 is constructed from ISOPLAST® polyurethane, or some other suitable material.

In operation, as shown inFIG. 3, asyringe170 is releasably connected to theproximal end124 of thehub120. Preferably, thesyringe170 includes a male luer connector171 that is sized to sealably fit into thepassageway126 from theproximal end130 of thepassageway126. Also preferably, thesyringe170 includesfemale threads172 that enable thesyringe170 to threadably engage themale threads132 at theproximal end124 of thehub120. The luer connector171 engages theflange168 and disposes theflange168, along with theplunger146, in a distal direction along thepassageway126. The distal mostdistal end164 of theplunger146 engages thedistal portion148 of theseal144, openingvalve140 through theseal142 along the through-openings150. Thepassageway126 at theproximal end124 of thehub120 is now in fluid communication with thehollow cannulating portion116 of theneedle110.

With thesyringe170 connected to theneedle assembly100, forming asyringe assembly180, thesyringe assembly180 is inserted into a patient according to known methods. When the inserting physician believes that thesyringe assembly180 is properly inserted into a desired blood vessel, the physician draws back on thesyringe plunger173, drawing a suction on thepassageway126 and thehollow cannulating portion116 of theneedle110. The suction draws blood from the vessel through the cannulatingportion116 of theneedle110, through the nowopen valve140 and thepassageway126 and into thesyringe chamber174. When the physician confirms proper placement of theneedle assembly100 by the blood flashback in thesyringe chamber174, the physician may then depress theplunger173, forcing the blood back through theneedle assembly100 and into the vessel so that thesyringe170 may be removed from theneedle assembly100.

As thesyringe170 is removed from theneedle assembly100 by unthreading thefemale threads172 on thesyringe170 from themale threads132 on thehub120 and sliding thesyringe170 proximally relative to theneedle assembly100, the luer connector171 is disposed away from theflange168. The resiliency of the silicon or other material comprising theseal142 allows thedistal portion148 of theseal142 to bias theplunger146 proximally, allowing thedistal portion148 of theseal142 to close, shutting off fluid communication between thepassageway126 and the cannulatingportion116 of theneedle110.

Thesyringe170 is now removed, and blood flow from the blood vessel through theneedle assembly110 is prevented by theseal142 that is now closed. As shown inFIG. 4, aguide wire190 is inserted into theproximal end124 of thehub120 according to known techniques. Thedistal end192 of theguide wire190 is able to be forced through the through-openings150 in thedistal portion148 of theseal142 so that theguide wire190 may be partially inserted into the blood vessel through the cannulatingportion116 of theneedle110. The resilience of theseal142 seals theseal142 around theguide wire190 so that blood is restricted from flowing proximally through theseal142.

Once theguide wire190 is in a desired location within the blood vessel, theneedle assembly100 may be removed from the patient by sliding theneedle assembly100 proximally along theguide wire190. With theguide wire190 in place, a catheter or other device (not shown) may be inserted into the blood vessel along theguide wire190.

Those skilled in the art will recognize that a device other than thesyringe170 may be connected to theneedle assembly100. For example, as shown inFIG. 5, abulb193 may be used. Thebulb193 is preferably of unitary construction and is constructed from a transparent or at least a translucent material, such as nylon or LEXAN ® polycarbonate. Thebulb193 includes a male luer fitting194 that is configured to fit into thepassageway126 in the same manner as the luer fitting171 on thesyringe170, as described above, and to open thevalve140 as described above. Thebulb193 includes aswivel lock195 having female threads196 that allow thebulb193 to be threadingly connected to theneedle assembly100 via themale threads132 at theproximal end124 of thehub120. Abulb portion197 allows any blood that flashes into thebulb193 through theneedle assembly110 to be easily seen due to the magnification properties of the bulbous shape of thebulb portion197. Thebulb193 also includes aproximal end198 that includes a female luer fitting198aand amale thread198bfor connection of an exterior device, such as thesyringe170, to thebulb193.

In operation, thebulb193 is releasably connected to theneedle hub120 by inserting the male luer fitting194 into thepassageway126 and engaging the thread196 on theswivel lock195 with thethread132 on thehub120. The male luer fitting194 engages theplunger146, forcing theplunger146 distally toward thedistal end122 of thehub120. Theplunger146 engages theseal142, opening thevalve140 through theseal142 along the through-openings150.

Although not shown, thesyringe170 may be connected to theproximal end198 of thebulb193 by inserting the male luer fitting171 into the female luer fitting198aand engaging thefemale thread172 with themale thread198b. The cannulatingportion116 of theneedle110 is now in fluid communication with thesyringe chamber174.

Theneedle assembly100 is next inserted into the patient according to known techniques. Thesyringe chamber174 is drawn proximally, drawing blood from the patient, through the cannulatingportion116 of theneedle110, through thevalve140, and into thebulb173, where the inserting physician can see the blood flash into thebulb portion197 to confirm that theneedle110 is inserted properly.

Thebulb193 is then disconnected from theneedle assembly100 and thevalve140 closes as described above. Theguide wire170 may now be inserted, as is also described above.

Those skilled in the art will recognize that thevalve140 may be used in other devices than theneedle assembly100 as described above. For example, thevalve140 may be inserted into aluer200, as shown inFIG. 6. Theluer200 may be connected to a proximal end of acatheter lumen202 and includes a proximalluer end204, a distalluer end206, and alongitudinal passage208 extending between the proximalluer end204 and the distalluer end206. Aluer wall209 forms theluer passage208. Theluer200 also includes alongitudinal axis210 extending through thepassage208 between the proximalluer end204 and the distalluer end206.

Thevalve140 is disposed within thelongitudinal passage208 such that theseal142 is disposed distal of theplunger146. Thesupport member144 is disposed between theplunger146 and theluer wall209. Operation of thevalve140 within theluer200 is the same as the operation of thevalve140 within theneedle hub120 as described above.

Further, the present invention is not limited to a syringe or a luer. Those skilled in the art will recognize that thevalve140 may be incorporated into any luer lock-type pathway that requires unobstructed flow when a male luer is inserted into the pathway and positive closure when the male luer is removed from the pathway.

It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.

Claims (17)

1. A needle assembly comprising:

a hollow needle having a pointed distal end and a proximal end;

a needle hub having a distal hub end fixedly connected to the needle, a proximal hub end having an opening, and a passageway extending therethrough between the distal hub end and the proximal hub end;

a valve disposed within the passageway, wherein the valve comprises a sealing member having at least one through-opening disposed therein, and the sealing member including a proximal portion defining a recess thereinto from a proximal valve end;

a non-resilient support member disposed in the passageway proximally of, adjacent to and in supportive engagement with the sealing member such that the proximal portion of the sealing member surrounds a distal end of the support member and the support member is secured in the passageway against proximal movement with respect to the passageway; and

a plunger disposed in and secured within the passageway proximate the sealing member and the support member and slidable between a first position wherein the at least one through-opening is closed such that the hollow needle and the proximal hub end are not in fluid communication with each other and a second position wherein the plunger biases the at least one through-opening to an open position, such that the hollow needle and the proximal hub end are in fluid communication with each other.

2. The needle assembly according toclaim 1, wherein the sealing member, the support member and the plunger are wholly disposed within the passageway, and the passageway includes a first inwardly directed protrusion proximate a distal end of the passageway to provide a forward stop for the valve, and a second inwardly directed protrusion proximally from the first inwardly directed protrusion and so positioned and shaped to permit insertion of the valve and the support member therepast during assembly and to thereafter be engaged by the support member to retain the support member and the valve distally thereof and between the first and second inwardly directed protrusions.

3. The needle assembly according toclaim 2, wherein the support member includes an inwardly directed protrusion so positioned and shaped to permit insertion of the distal portion of the plunger therepast during assembly, and thereafter to maintain the plunger within the needle hub while permitting movement of the plunger between its first and second positions in stoppable cooperation with an outwardly directed protrusion along the distal portion of the plunger.

4. The needle assembly according toclaim 1, wherein the needle hub further comprises a longitudinal axis extending therethrough.

5. The needle assembly according toclaim 4, wherein the seal is generally disposed about the longitudinal axis.

6. The needle assembly according toclaim 1, wherein the needle hub is made as a single unitary piece defining the entire passageway into which the valve, support member and plunger are inserted.

7. The needle assembly according toclaim 1, further comprising a bulb releasably connected to the proximal end of the needle hub.

8. A method of inserting a guide wire into a blood vessel comprising:

providing the needle assembly according toclaim 1;

providing a body having a luer connector extending therefrom;

providing a guide wire having a distal end;

releasably connecting the body to the proximal end of the hub, wherein the luer connector disposes the plunger in a distal direction, wherein the plunger biases the at least one through-opening from a closed position to an open position;

inserting the pointed distal end of the needle into the blood vessel;

confirming proper placement of the needle in the blood vessel by drawing blood into the body;

removing the body from the needle assembly, wherein the luer connector is disposed away from the plunger, wherein the sealing member biases the plunger in a proximal direction, and

wherein the at least one through-opening returns to the closed position;

inserting the distal end of the guide wire into the passageway, through the at least one through-opening, through the hollow needle and into the blood vessel; and

removing the needle assembly from the blood vessel by sliding the needle assembly proximally along the guide wire.

9. The method according toclaim 8, wherein providing the body comprises providing a syringe.

10. The method according toclaim 8, wherein providing the body comprises providing a bulb.

11. The method according toclaim 10, further comprising connecting a syringe to the bulb.

12. A needle assembly comprising:

a hollow needle having a pointed distal end, a proximal end, and a longitudinal axis extending between the distal end and the proximal end;

a needle hub having a distal hub end fixedly connected to the needle, a proximal hub end having an opening, and a passageway extending therethrough along the longitudinal axis between the distal hub end and the proximal hub end;

a valve disposed within the passageway, wherein the valve comprises a sealing member having at least one through-opening disposed along the longitudinal axis, and the sealing member including a proximal portion defining a recess thereinto from a proximal valve end;

a non-resilient support member disposed in the passageway proximally of, adjacent to and in supportive engagement of the sealing member such that the proximal portion of the sealing member surrounds a distal end of the support member and the support member is secured in the passageway against proximal movement with respect to the passageway; and

a plunger disposed in and secured within the passageway proximate the sealing member and slidable between a first position wherein the at least one through-opening is closed such that the hollow needle and the proximal hub end are not in fluid communication with each other and a second position wherein the plunger biases the at least one through-opening to an open position, such that the hollow needle and the proximal hub end are in fluid communication with each other.

13. The needle assembly according toclaim 12, wherein the sealing member, the support member and the plunger are wholly disposed within the passageway, and the passageway includes a first inwardly directed protrusion proximate a distal end of the passageway to provide a forward stop for the valve, and a second inwardly directed protrusion proximally from the first inwardly directed protrusion and so positioned and shaped to permit insertion of the valve and the support member therepast during assembly and to thereafter be engaged by the support member to retain the support member and the valve distally thereof and between the first and second inwardly directed protrusions.

14. The needle assembly according toclaim 13, wherein the support member includes an inwardly directed protrusion so positioned and shaped to permit insertion of the distal portion of the plunger therepast during assembly, and thereafter to maintain the plunger within the needle hub while permitting movement of the plunger between its first and second positions in stoppable cooperation with an outwardly directed protrusion along the distal portion of the plunger.

15. The needle assembly according toclaim 12, wherein the needle hub is made as a single unitary piece defining the entire passageway into which the valve, support member and plunger are inserted.

16. The needle assembly according toclaim 12, further comprising a bulb releasably connected to the proximal end of the needle hub.

17. A combination passageway and valve comprising:

a passageway comprising:

a first end;

a second end;

a longitudinal axis extending between the first end and the second end;

a passage fluidly communicating the first end and the second end; and

a wall forming the passageway; and

a valve disposed in the passage between the first end and the second end, wherein the valve comprises:

a sealing member having at least one through-opening disposed along the longitudinal axis;

a support member disposed in the passageway proximally of, adjacent to and supportive of the valve such that a proximal end of the valve surrounds a distal end of the support member and the support member is secured in the passageway against proximal movement with respect to the passageway; and

a plunger disposed proximate the sealing member and the support member and slidable between a first position wherein the at least one through-opening is closed such that the first end and the second end are not in fluid communication with each other and a second position wherein the plunger biases the at least one through-opening to an open position, such that the first end and the second end are in fluid communication with each other,

wherein the sealing member, the support member and the plunger are wholly disposed within the passageway, and the passageway includes a first inwardly directed protrusion proximate the distal end of the passageway to provide a forward stop for the valve, and a second inwardly directed protrusion proximally from the first inwardly directed protrusion and so positioned and shaped to permit insertion of the valve and the support member therepast during assembly and to thereafter be engaged by the support member to retain the support member and the valve distally thereof and between the first and second inwardly directed protrusions.

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